The Safe-by-Design approach in synthetic biology holds the promise of designing the building blocks of life in an organism guided by the value of safety. This paves a new way for using biotechnologies safely. However, the Safe-by-Design approach moves the bulk of the responsibility for safety to the actors in the research and development phase. Also, it assumes that safety can be defined and understood by all stakeholders in the same way. These assumptions are problematic and might actually undermine safety. (...) This research explores these assumptions through the use of a Group Decision Room. In this set up, anonymous and non-anonymous deliberation methods are used for different stakeholders to exchange views. During the session, a potential synthetic biology application is used as a case for investigation: the Food Warden, a biosensor contained in meat packaging for indicating the freshness of meat. Participants discuss what potential issues might arise, how responsibilities should be distributed in a forward-looking way, who is to blame if something would go wrong. They are also asked what safety and responsibility mean at different phases, and for different stakeholders. The results of the session are not generalizable, but provide valuable insights. Issues of safety cannot all be taken care of in the R&D phase. Also, when things go wrong, there are proximal and distal causes to consider. In addition, capacities of actors play an important role in defining their responsibilities. Last but not least, this research provides a new perspective on the role of instruction manuals in achieving safety. (shrink)

The Safe-by-Design approach in synthetic biology holds the promise of designing the building blocks of life in an organism guided by the value of safety. This paves a new way for using biotechnologies safely. However, the Safe-by-Design approach moves the bulk of the responsibility for safety to the actors in the research and development phase. Also, it assumes that safety can be defined and understood by all stakeholders in the same way. These assumptions are problematic and might actually undermine safety. (...) This research explores these assumptions through the use of a Group Decision Room. In this set up, anonymous and non-anonymous deliberation methods are used for different stakeholders to exchange views. During the session, a potential synthetic biology application is used as a case for investigation: the Food Warden, a biosensor contained in meat packaging for indicating the freshness of meat. Participants discuss what potential issues might arise, how responsibilities should be distributed in a forward-looking way, who is to blame if something would go wrong. They are also asked what safety and responsibility mean at different phases, and for different stakeholders. The results of the session are not generalizable, but provide valuable insights. Issues of safety cannot all be taken care of in the R&D phase. Also, when things go wrong, there are proximal and distal causes to consider. In addition, capacities of actors play an important role in defining their responsibilities. Last but not least, this research provides a new perspective on the role of instruction manuals in achieving safety. (shrink)

In part one, I identify the core logical structure of the precautionary principle and distinguish it from the various key concepts that appear in the many different formulations of the principle. I survey these concepts and suggest a program of further conceptual analysis. In part two, I examine a particular version of the precautionary principle dubbed “the catastrophe principle” and criticize it in light of its similarities to the principle at work in Pascal’s Wager. I conclude with some suggestions for (...) advocates of the precautionary principle who wish their formulation to avoid the pitfalls confronting the catastrophe principle. (shrink)

This paper analyses the nature of the relationship between risk and responsibility. Since neither the concept of risk nor the concept of responsibility has an unequivocal definition, it is obvious that there is no single interpretation of their relationship. After introducing the different meanings of responsibility used in this paper, we analyse four conceptions of risk. This allows us to make their link with responsibility explicit and to determine if a shift in the connection between risk and responsibility can be (...) outlined. (1) In the engineer’s paradigm, the quantitative conception of risk does not include any concept of responsibility. Their relationship is indirect, the locus of responsibility being risk management. (2) In Mary Douglas’ cultural theory, risks are constructed through the responsibilities they engage. (3) Rayner and (4) Wolff go further by integrating forms of responsibility in the definition of risk itself. Analysis of these four frameworks shows that the concepts of risk and responsibility are increasingly intertwined. This tendency is reinforced by increasing public awareness and a call for the integration of a moral dimension in risk management. Therefore, we suggest that a form of virtue-responsibility should also be integrated in the concept of risk. (shrink)

Several nation states have reasons to halt the import of genetically modified organisms. The current international trend towards a regime of free trade makes such bans problematic. Whether a nation state is deemed justified in banning a certain product is strongly connected to discussions about what are acceptable criteria for proof of risk. The determination of these criteria hinges upon considerations of individual and national autonomy. This paper compares two different points of view in the debate: the WTO opposed to (...) the UN. A distinction between internal and external autonomy explains the differences in approach between the UN and the WTO. The conclusion is reached that adequate respect for autonomy requires a certain amount of flexibility in the criteria for proof of risk. (shrink)

Safe-by-design aims at addressing safety issues already during the R&D and design phases of new technologies. SbD has increasingly become popular in the last few years for addressing the risks of emerging technologies like nanotechnology and synthetic biology. We ask to what extent SbD approaches can deal with uncertainty, in particular with indeterminacy, i.e., the fact that the actual safety of a technology depends on the behavior of actors in the value chain like users and operators. We argue that while (...) indeterminacy may be approached by designing out users as much as possible in attaining safety, this is often not a good strategy. It will not only make it more difficult to deal with unexpected risks; it also misses out on the resources that users can bring for achieving safety, and it is undemocratic. We argue that rather than directly designing for safety, it is better to design for the responsibility for safety, i.e., designers should think where the responsibility for safety is best situated and design technologies accordingly. We propose some heuristics that can be used in deciding how to share and distribute responsibility for safety through design. (shrink)

Safe-by-design aims at addressing safety issues already during the R&D and design phases of new technologies. SbD has increasingly become popular in the last few years for addressing the risks of emerging technologies like nanotechnology and synthetic biology. We ask to what extent SbD approaches can deal with uncertainty, in particular with indeterminacy, i.e., the fact that the actual safety of a technology depends on the behavior of actors in the value chain like users and operators. We argue that while (...) indeterminacy may be approached by designing out users as much as possible in attaining safety, this is often not a good strategy. It will not only make it more difficult to deal with unexpected risks; it also misses out on the resources that users can bring for achieving safety, and it is undemocratic. We argue that rather than directly designing for safety, it is better to design for the responsibility for safety, i.e., designers should think where the responsibility for safety is best situated and design technologies accordingly. We propose some heuristics that can be used in deciding how to share and distribute responsibility for safety through design. (shrink)

Using long-term anthropological observations at the Center for Biological and Environmental Nanotechnology in Houston, Texas, the article demonstrates in detail the creation of new objects, new venues and new modes of veridiction which have reoriented the disciplines of materials chemistry and nanotoxicology. Beginning with the confusion surrounding the meaning of ‘implications’ and ‘applications’ the article explores the creation of new venues (CBEN and its offshoot the International Council on Nanotechnology); it then demonstrates how the demands for a responsible, safe or (...) ethical science were translated into new research and experiment in and through these venues. Finally it shows how ‘safety by design’ emerged as a way to go beyond implications and applications, even as it introduced a whole new array of controversies concerning its viability, validity and legitimacy. (shrink)